NM-7000
FDA 510(k) clearance K111329 · decided 2011-09-06
Clearance details
- K-number
- K111329
- Device name
- NM-7000
- Applicant
- Nuga Medical Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2011-05-11
- Decision date
- 2011-09-06
- Days to decision
- 118 days
- Clearance type
- Traditional
- Product code
- JFB
- Device class
- 2
- Regulation number
- 890.5880
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Echo, OR, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.